Traditional diagnostic pathology relies on a narrowly scoped set of expertise and technologies to identify and diagnose diseases and determine treatment efficacy based on tissue examination. However, exploratory pathology  incorporates a wide range of methodologies and specialty areas – including but not limited to veterinary pathology and biomedical research – to help researchers better understand mechanisms of toxicity, evaluate impact on disease, and ultimately enrich and possibly even expedite the development of new therapies.

To highlight the benefits of exploratory pathology, StageBio held a live webinar titled, “Exploratory Pathology in Action: Advancing Nonclinical Drug Development Across Therapeutic Areas.” Senior Pathologist Tracey Papenfuss, DVM, MS, PhD, DACVP, and Vice President of Pathology Solutions Stephanie M. Shrader, DVM, PhD, DACVP, introduced webinar attendees to the concept of exploratory pathology, complete with an overview, use case examples, and how StageBio can support their exploratory pathology needs.

The webinar is now available on demand, and you can access it by clicking the link in the paragraph above. Otherwise, keep reading for key takeaways from the event to understand why and how exploratory pathology is critical to improving and streamlining early-stage research, efficacy and toxicology, safety assessments, and the entirety of the drug development process.

An overview of exploratory pathology

Exploratory pathology is often perceived as synonymous with early stages of disease discovery. However, it goes far beyond initial diagnosis, encompassing all aspects of the drug development lifecycle. Exploratory pathology involves more than just examining tissue samples under a microscope; it includes a broader investigation into pathogenic mechanisms, biological processes, and translational medicine. The aim is to inform research decisions, optimize therapeutic developments, and address safety risks from the earliest stages of discovery through to preclinical safety assessments.

The benefits of exploratory pathology

There are numerous benefits to incorporating exploratory pathology into drug development, such as

A better understanding of disease mechanisms

Exploratory pathology allows for deeper insight into how diseases function at a cellular and molecular level. This is crucial for identifying novel therapeutic targets and improving treatment strategies.

Interdisciplinary collaboration

Exploratory pathology facilitates cooperation between pathologists and scientists from various fields, ensuring findings are interpreted within the broader biological context. This holistic approach enhances the accuracy and relevance of research outcomes.

A streamlined drug development process

Exploratory pathology streamlines the development process by identifying potential safety issues early, reducing the likelihood of late-stage failures. For instance, immunohistochemistry (IHC) and other specialized techniques can pinpoint specific changes within tissues, offering insight into how therapies interact with biological systems on a cellular level.

More comprehensive safety assessments

While traditionally associated with early research, exploratory pathology also influences later stages of drug development, particularly in preclinical and safety assessments. Pathologists can uncover the underlying causes of toxicological findings, helping to determine their relevance and potential impact on human health.

This exploratory approach can be crucial when unexpected results emerge during GLP-compliant studies, necessitating additional investigations to ensure comprehensive safety evaluations. Through histopathological assessments, pathologists can provide a detailed understanding of how drugs affect biological tissues, supporting a more nuanced interpretation of safety data.

Improved model development

Exploratory pathology assists in the creation and validation of disease models that closely mimic human conditions. These reliable models improve the accuracy of preclinical studies, leading to better predictions of drug efficacy and safety.

Guided drug optimization

Exploratory pathology plays a vital role in refining drug candidates by evaluating efficacy and toxicity during lead optimization studies. This ensures that only the most promising candidates move forward, enhancing the efficiency of the development pipeline.

Example: Exploratory pathology in an ocular study

In the context of an ocular study, a pathologist with expertise in ocular pathology can assist an early discovery ocular study by:

• Evaluating proof-of-concept studies for novel therapeutics and vehicles, novel surgical approaches, and devices or implants
• Applying their specialized knowledge to evaluate disease models used for screening, such as glaucoma and diabetic retinopathy
• Assisting in accurate model development and translational research through their understanding of species-specific anatomical and physiological differences

In other words, involving a pathologist with expertise in ocular pathology early in an ocular study design can help ensure proper tissue collection, fixation, and analysis. This culminates in more precise and relevant study results.

A key benefit of exploratory pathology for safety assessments

Exploratory pathology significantly enhances the safety assessment phase of drug development by offering a thorough examination of potential adverse effects and toxicological profiles of new therapeutic candidates.

One of the primary benefits is its ability to uncover the underlying mechanisms behind toxicological findings, which is crucial for distinguishing between harmless and genuinely harmful changes in tissues. This detailed understanding helps in assessing the relevance and severity of observed pathologies, ensuring that safety assessments are comprehensive and accurate.

Moreover, exploratory pathology facilitates early identification of safety issues, allowing for timely modifications in the development process. By providing an in-depth analysis of how a drug interacts with biological systems across different doses and administration routes, it preempts possible adverse outcomes in clinical trials. This proactive approach can save significant time and resources by preventing costly late-stage failures and guiding safer and more effective drug dosing regimens.

Another critical advantage is the integration of various data types, including clinical pathology, molecular diagnostics, and functional assays, to form a holistic view of a drug’s safety profile. This interconnected data analysis enhances the interpretation of toxicological findings, promoting a more nuanced understanding of drug effects.

Ultimately, the comprehensive insights gained from exploratory pathology inform better decision-making, ensuring that only the safest and most effective therapeutics progress through the development pipeline, thereby protecting patient health and enhancing the overall success of pharmaceutical advancements.

Why partner with StageBio for exploratory pathology services

StageBio is uniquely positioned to help clients due to our comprehensive range of specialized pathology services and our team of highly qualified experts. With 22 board-certified veterinary pathologists who possess deep expertise in various fields such as toxicologic, ocular, immunology, and neuropathology, we can provide tailored support for complex studies.

Additionally, our state-of-the-art facilities in the United States and Europe are equipped with advanced technology for histology, slide scanning, image analysis, and morphometry, ensuring high-quality and accurate results.

Moreover, we offer customized study packages and personalized consultation, ensuring that clients receive the specific support they need to advance their research efficiently and effectively. This combination of expertise, advanced facilities, and client-focused services makes StageBio an ideal partner for exploratory pathology projects.

Watch the on-demand webinar now to learn more about the benefits of exploratory pathology

Access and watch the webinar now here  or get in touch. Remember, to get the full benefit of a partnership with StageBio, reach out as early as possible in your drug development process!